Enesi Pharma and Walter Reed Army Institute of Research (WRAIR) sign Cooperative R&D Agreement (CRADA) for Needle-Free Solid-Dose Vaccine for Shigella Infection

Oxford, UK – 24th September 2018. Enesi Pharma, an innovative pharmaceutical company developing unique injectable solid dose vaccine products, announces it has entered a Cooperative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR), a United States Department of Defense Laboratory, regarding Shigella vaccine development.

The CRADA is focused on the development of a robust and stable solid-dose formulation of WRAIR’s Shigella flexneri 2a artificial Invaplex (Sfl2a InvaplexAR) vaccine for delivery via Enesi Pharma’s ImplaVax® technology. A vaccine able to protect against Shigella is a high-priority objective for the US Army and is an equally high-priority for vaccine developers targeting paediatric populations in endemic areas of the world.

Commenting on the collaboration, David Hipkiss, CEO of Enesi Pharma, said:

“We have made great progress at Enesi Pharma with the development of our ImplaVax® needle-free injection platform since the launch of the company in 2017. In parallel, we have consulted with vaccine manufacturers, emerging companies and research institutes around the world to enhance our understanding of their needs and to discuss and execute a number of potential collaborations designed to demonstrate the benefits that ImplaVax could deliver for improving human health.

 “We are therefore delighted to announce this major collaboration with WRAIR to combine our respective expertise and evaluate the possibilities of a solid-dose version of its Shigella vaccine. WRAIR is a world-renowned centre of vaccine discovery and development, with almost 50% of the world’s marketed products today benefitting from a common WRAIR heritage. We are excited about the programme and look forward to working closely with WRAIR over the coming years.”

Dr Robert Kaminski, Chief, Subunit Enteric Vaccines & Immunology, Branch of Bacterial Diseases at WRAIR, added:

“WRAIR Bacterial Diseases Branch is pleased to be a part of this collaboration. The potential benefits of Enesi’s ImplaVax system should be considered with respect to vaccination against Shigella, particularly in those challenging environments where storage and retention of activity is a critical factor. We look forward to working with the Enesi team in advancing this project.”

According to the World Health Organization, Shigella infection (shigellosis) is the most communicable form of bacterial diarrhoeal disease and is responsible for approximately 165 million cases of severe dysentery each year, with the overwhelming majority of these cases occurring in developing countries and involving children less than five years of age. More than one million people are estimated to die from shigellosis each year. In addition, some 580,000 cases of shigellosis per year are reported among travellers and military personnel from industrialised countries.

Under the collaboration, WRAIR’s Invaplex Shigella vaccine will be provided to Enesi, and Enesi will create a solid-dose formulation for needle-free injection using its ImplaVax® technology. WRAIR will test the solid-dose product for biochemical integrity and immunogenicity in Shigella disease models. Data from the collaboration will be shared between Enesi Pharma and WRAIR, and could, pending the outcome, form the foundation of future commercial opportunities.